UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026578 |
|---|---|
| Receipt number | R000030516 |
| Scientific Title | Examination of effects of bronchial thermoplasty on mediators in the respiratory tract, exercise induced asthma, asthma control and QOL and confirmation of safety |
| Date of disclosure of the study information | 2017/03/17 |
| Last modified on | 2017/03/16 15:15:50 |
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Basic information
Public title
Examination of effects of bronchial thermoplasty on mediators in the respiratory tract, exercise induced asthma, asthma control and QOL and confirmation of safety
Acronym
Examination of effects of bronchial BT on mediators in the respiratory tract, exercise induced asthma, asthma control and QOL and confirmation of safety
Scientific Title
Examination of effects of bronchial thermoplasty on mediators in the respiratory tract, exercise induced asthma, asthma control and QOL and confirmation of safety
Scientific Title:Acronym
Examination of effects of bronchial BT on mediators in the respiratory tract, exercise induced asthma, asthma control and QOL and confirmation of safety
Region
| Japan |
Condition
Condition
severe refractory asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the efficaecy of BT on mediators in the respiratory tract, exercise induced asthma, asthma control and QOL and confirmation of safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Decrease rate of FEV 1 before and after exercise load at 52 weeks after the last BT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
BT is performed at least three weeks apart, and preformed three times in tota
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult (over 20 years) patients with severe refractory asthma who require regular maintenance medications of inhaled corticosteroids and a long-acting beta agonist.
Key exclusion criteria
Patients with BT contraindicated
Patients incapable of general anesthesia
Patients whose exercise stress test is considered contraindicated
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Johsuke Hara |
Organization
Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name
Department of Respiratory Medicine
Zip code
Address
13-1 Takara-machi Kanazawa Ishikawa
TEL
076-265-2000
hara0728@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Johsuke Hara |
Organization
Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name
Department of Respiratory Medicine
Zip code
Address
13-1 Takara-machi Kanazawa Ishikawa
TEL
076-265-2000
Homepage URL
hara0728@gmail.com
Sponsor or person
Institute
Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Metabolomics
Medical Institute of Bioregulation
Kyushu University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2017 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 16 | Day |
Last modified on
| 2017 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030516
